Percutaneous implantation of self-expandable aortic valve in high risk patients with severe aortic stenosis: The first experiences in Serbia

Milan A. Nedeljković; Branko Beleslin; Milorad Tesić; Vladan Vukcević; Goran Stanković; Siniša Stojković; Dejan Orlić; Ilija Bilbija; Miloš Matković; Tijana Simić; Nemanja Menković; Igor Mrdović; Gian Paolo Ussia; Zoran Perišić; Momčilo Babić

doi:10.2298/7161

Milan A. Nedeljković Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Branko Beleslin Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Milorad Tesić Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Vladan Vukcević Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Goran Stanković Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Siniša Stojković Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Dejan Orlić Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Ilija Bilbija Clinic for Cardiac Surgery Clinical Center of Serbia, Belgrade, Serbia
Miloš Matković Clinic for Cardiac Surgery Clinical Center of Serbia, Belgrade, Serbia
Tijana Simić Center for Anesthesiology and Reanimation Clinical Center of Serbia, Belgrade, Serbia
Nemanja Menković Clinic for Radiology, Clinical Center of Serbia, Belgrade, Serbia
Igor Mrdović Clinic for Cardiology Clinical Center of Serbia, Belgrade, Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia
Gian Paolo Ussia Department of Cardiovascular Disease, Tor Vergata University of Rome, Rome, Italy
Zoran Perišić Clinic for Cardiovascular Diseases, Clinical Center Niš, Faculty of Medicine, University of Niš, Niš, Serbia
Momčilo Babić National Health Insurance Fund, Belgrade, Serbia

DOI: https://doi.org/10.2298/7161

Keywords: aortic valve stenosis, transcatheter aortic valve replacement, severity of illness index, risk factors, cardiac surgical procedures,

Abstract

Background/Aim. Aortic stenosis (AS) is the most common valvular heart disease in elderly people, with rather poor prognosis in symptomatic patients. Surgical valve replacement is the therapy of choice, but a significant number of patients cannot undergo surgical procedure. We presented initial experience of transcatheter aortic valve implantation (TAVI) performed in Catheterization Laboratory of the Clinic for Cardiology, Clinical Center of Serbia. Methods. The procedures were performed in 5 patients (mean age 76 ± 6 years, 2 males, 3 female) with severe and symptomatic AS with contraindication to surgery or high surgical risk. The decision to perform TAVI was made by the heart team. Pre-procedure screening included detailed clinical and echocardiographic evaluation, coronary angiography and computed tomography scan. In all the patients we implanted a self-expandable aortic valve (Core Valve, Medtronic, USA). Six months follow-up was available for all the patients. Results. All interventions were successfully performed without significant periprocedural complications. Immediate hemodynamic improvement was obtained in all the patients (peak gradient 94.2 ± 27.6 to 17.6 ± 5.2 mmHg, p < 0.001, mean pressure gradient 52.8 ± 14.5 to 8.0 ± 2.1 mmHg, p < 0.001). None of the patients developed heart block, stroke, vascular complication or significant aortic regurgitation. After 6 months, the survival was 100% with New York Heart Association (NYHA) functional improvement in all the patients. Conclusion. This successful initial experience provides a solid basis to treat larger number of patients with symptomatic AS and high surgical risk who are left untreated.

References

Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012; 33(19): 2451−96.

Leon MB, Smith CR, Mack M, Miller CD, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363(17): 1597−607.

Généreux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis J, et al. Transcatheter aortic valve implantation 10-year anni-versary: review of current evidence and clinical implications. Eur Heart J 2012; 33(19): 2388−98.

Athappan G, Gajulapalli R, Sengodan P, Bhardwaj A, Ellis SG, Svensson L, et al. Influence of transcatheter aortic valve re-placement strategy and valve design on stroke after transcathe-ter aortic valve replacement: a meta-analysis and systematic re-view of literature. J Am Coll Cardiol 2014; 63(20): 2101−10.

Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, et al. Transcatheter aortic valve implantation: 3-year out-comes of self-expanding CoreValve prosthesis. Eur Heart J 2012; 33(8): 969−76.

Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aor-tic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011; 58(20): 2130−8.

Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, et al. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sa-pien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention 2010; 5(6): 659−65.

Martínez GJ, Seco M, Jaijee SK, Adams MR, Cartwright BL, Forrest P, et al. Introduction of an interdisciplinary heart team-based transcatheter aortic valve implantation programme: short and mid-term outcomes. Intern Med J 2014; 44(9): 876−83.

Davies WR, Thomas MR. European experience and perspectives on transcatheter aortic valve replacement. Prog Cardiovasc Dis 2014; 56(6): 625−34.

Giordana F, D'Ascenzo F, Nijhoff F, Moretti C, D'Amico M, Biondi ZG, et al. Meta-analysis of predictors of all-cause mortality af-ter transcatheter aortic valve implantation. Am J Cardiol 2014; 114(9): 1447−55.

Zajarias A, Cribier AG. Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol 2009; 53(20): 1829−36.

Nedeljkovic M, Vukcevic V, Beleslin B, Stankovic G, Tesic M, Stojkovic S, et al. First transcatheter implantations of aortic valve in Serbia. Srce i krvni sudovi 2014; 33(1): 30−4. (Serbian)

Agarwal S, Tuzcu EM, Krishnaswamy A, Schoenhagen P, Stewart WJ, Svensson LG,et al. Transcatheter aortic valve replacement: current perspectives and future implications. Heart 2015; 101(3): 169–77.

Abdel-Wahab M, Mehilli J, Frerker C, Neumann F, Kurz T, Tölg R, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve re-placement: the CHOICE randomized clinical trial. JAMA 2014; 311(15): 1503−14.

Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 2011; 32(2): 198−204.

Chiam PT, Ewe SH. An update on complications associated with transcatheter aortic valve implantation: stroke, paravalvu-lar leak, atrioventricular block and perforation. Future Cardiol 2013; 9(5): 733−47.

Zahn R, Gerckens U, Linke A, Sievert H, Kahlert P, Hambrecht R, et al. Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol 2013; 112(2): 272−9.

Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mor-tality after transcatheter aortic valve implantation in 663 pa-tients with severe aortic stenosis. Circulation 2011; 123(3): 299−308.

Edmunds LH. Evolution of prosthetic heart valves. Am Heart J 2001; 141(5): 849−55.

Harken DE, Soroll HS, Taylor WJ, et al. Aortic valve replace-ment. In: Meredino KA, editor. Prosthetic valves for cardiac surgery. Springfild (IL): Charles C Thomas; 1961. p. 508–25.

Cribier A. Historical perspective: 10th year anniversary of TA-VI. EuroIntervention. 2012; 8(Suppl Q): Q15−7.

Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Mak-kar RR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012; 366(18): 1686−95.

Cribier A, Durand E, Eltchaninoff H. Patient selection for TAVI in 2014: is it justified to treat low- or intermediate-risk pa-tients? The cardiologist's view. EuroIntervention 2014; 10 Suppl U: U16−21.